Addressing the Social Needs of Children Attending a Weight Management Program: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Recruitment Rates
研究概览
简要总结
This study aims to improve the treatment of a common, chronic health concern for children: obesity. It has the potential to improve the care we provide by testing an intervention that addresses social needs and the important upstream factors that influences health outcomes.
详细描述
Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following:
- To determine the feasibility of implementation and delivery of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program at McMaster Children's Hospital, which will include recruitment rates, uptake of the intervention, and follow-up of participants.
- To understand impact on health outcomes of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program including change in i) body mass index z score (zBMI); ii) change in body composition; and iii) change in health-related quality of life.
Hypothesis
We hypothesize that health outcomes of children with obesity are connected to the social determinants of health, and that an intervention which screens for and refers to community supports will improve child obesity outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts will be blind to the group allocation. Group allocation will be concealed until the final data analysis is performed. Families, research staff and clinical staff will not be blinded to the group allocation.
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in the weight management program
排除标准
- •Children in the care of child protection services and/or living in group or foster care. Children in these settings will not be living within typical family-systems to have social needs addressed by this intervention.
- •Parents who cannot read and write in English
结局指标
主要结局
Recruitment Rates
时间窗: 6 months
Recruitment rate refers to the number of participants enrolled and is measured by the number of consent forms signed or implied. Recruitment will be successful if 80% of our target sample is met.
Uptake of Intervention
时间窗: 6 months
Uptake of the intervention refers to the number of enrolled families who completed all aspect of the intervention. Elements that are part of the uptake include: social history following enrollment as well as the quality of life questionnaires and use of service questionnaire at enrolment and 6-months. Uptake will be considered successful if \>80% of families complete the intervention.
Follow-up of Participants
时间窗: 6 months
Follow-up of participants refers to the participants attending all of their scheduled study visits. The study will be considered successful if \>90% of participants complete all study visits.
次要结局
- Change in Quality of Life(6 Months)
- Change in Body Mass Index Z-Score(6 Months)
- Change in Body Composition(6 Months)